REGULATORY SUBMISSION

Big Leap research offers you solution to address the complexities in regulatory submission and compliance with applicable agency. The delay would impact clients’ development plan, even, the non-compliance could be crisis to which no one can afford.

By delivering submission service, we would stay you more focused on expertise and core business with expediting your clinical trial to market.

With more than 5 years working with local and Viet Nam minister of health ethic committee, we elaborate experienced, trusted relationship and effective communication channel. Unified across four areas over Viet Nam, Big Leap help you deploy multi-sites trial feasibly.

Working closely with client to understand their plan, our team tailors solution to address issue with consultant from our expert and regulatory member. The two-side interaction with regulatory helps us get deep understanding and innovative solution. We are committed to closely supervising, responding to issue, and implementing the mitigation plan.

Big Leap Company offers a broad spectrum of submission service ranging from plan to end-trial:

  • Trial strategic plan
  • Regulatory consultant
  • Customization, review and QC of study dossier (such as: Thesis, ICF…)
  • Coordination, support and follow up for multi-site Ethic committee
  • Regulatory submission and approval (MoH EC, Import/Export license, People committee)
  • Regulatory assistance regarding VNM MoH, FDA, EMA
  • Clinical study report acceptance by site and MoH EC

Our commitment is to deliver the service as per agreement as our core value, quality and productivity.

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